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Clinical Trials/NCT04437849
NCT04437849
Completed
N/A

Trial Clínico: Utilidad Del Telemonitoreo en Pacientes Con IC Como Medio de Apoyo Para la autogestión de la Enfermedad

Universidad Nacional de Tucuman1 site in 1 country30 target enrollmentAugust 1, 2018
ConditionsHeart Failure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Universidad Nacional de Tucuman
Enrollment
30
Locations
1
Primary Endpoint
Changes in quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This randomized controlled clinical trial compares a home telemonitoring system (HTS) versus usual care during a 90 days follow-up period of Heart Failure (HF) ambulatory patients, in order to evaluate if the use of the HTS improves quality of life and HF related-knowledge. The study was reviewed and approved by the Methodological Committee and by the Research Ethics Committee from the Provincial Health System, according to the Declaration of Helsinki. Written informed consent was obtained before randomization.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
May 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lucía María Yanicelli

Principal Investigator PhD in Exact Sciences and Engineering

Universidad Nacional de Tucuman

Eligibility Criteria

Inclusion Criteria

  • were over 18 years with a primary diagnosis of HF,
  • had been hospitalized at least once time as a consequence of a HF decompensation,
  • had a Smartphone,
  • had access to WiFi,
  • had access to a weight scale and to a blood-pressure monitor

Exclusion Criteria

  • illiterate patients,
  • had learning difficulties,
  • had a cognitive impairment sufficient to interfere with the use of the telemonitoring system, or had a severe depression that could interfere with their quality of life perception.

Outcomes

Primary Outcomes

Changes in quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ)

Time Frame: 3-month

Changes in HF related knowledge through the Knowledge of CHF questionnaire

Time Frame: 3-month

Study Sites (1)

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